Philadelphia, Pennsylvania

Trasylol Recall Problems

Rockville, MD: Earlier this month, Bayer announced that it was recalling remaining Trasylol stocks from the US market. The move comes after repeated studies found that patients given Trasylol during open heart surgery had a higher risk of kidney failure, strokes and death than patients given a different drug.

The recall of Trasylol was foreseeable, given all the studies linking the drug to severe adverse reactions and leading many people to wonder why Bayer and the FDA took so long to recall Trasylol?

Bayer has allegedly known for a long time that there were problems with Trasylol. After all, the company “mistakenly” failed to give the FDA results of its own clinical study. That study linked Trasylol to an increased risk of strokes, congestive heart disease and kidney failure. Worse, even though Bayer representatives appeared at an FDA meeting to discuss possible risks associated with Trasylol, those representatives did not mention the clinical trial or its result.

Despite this, Trasylol stayed on the market and was allowed to continue harming patients.

In 2006, two studies were published that confirmed the risks of serious adverse reactions to patients given Trasylol. One of the studies, published in the New England Journal of Medicine, concluded that stopping the use of Trasylol would prevent between 10,000 and 11,000 cases of kidney failure requiring dialysis a year. Furthermore, $1 billion a year in dialysis costs would be saved.

Despite this, Trasylol stayed on the market and was allowed to continue harming at least 10,000 patients a year.

In 2007, a Canadian study was halted early because researchers felt it was no longer ethical to continue after patients given Trasylol had a higher risk of dying than patients given a different drug.

In response, Bayer stopped selling Trasylol. However, the drug had been on the market for 14 years. If Trasylol caused 10,000 cases of kidney failure a year for 14 years, at least 140,000 people were harmed by the drug. But that only counts patients who suffered kidney failure after being given Trasylol—it does not count patients who suffered strokes or other heart problems, and there are likely many of those.

Finally, in 2008, two studies were released that once again showed the high degree of risk associated with the use of Trasylol. One study found that 6.4 percent of patients given Trasylol died within 30 days of their open heart surgery. The second study found that patients given Trasylol had a 64 percent higher risk of death than patients given a different drug.

Finally, all remaining stock of Trasylol was recalled. But this came much too late for many patients.

The results of the clinical trial should have been enough to stop Bayer from marketing Trasylol. Instead, however, Bayer went ahead with Trasylol and allowed it to be given to countless patients during open heart surgery. Now, many of those patients have suffered serious adverse reactions and some have died. They should not have been exposed to a drug with such high risks in the first place.

Patients who suffered adverse reactions to Trasylol, as well as those who have had a loved one die after being given the drug, are now in the process of filing lawsuits against Bayer, alleging the company was not honest about the risks associated with the drug.

If you or someone you love were harmed by Trasylol, you may be eligible to join a lawsuit against Bayer. Contact a lawyer to discuss your legal options.

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